Device product
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Z-0797-2020
Product summary
- Firm
- Teleflex Medical
- Event
- Event 82307
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13104 devices
- Official record key
device-enforcement:Z-0797-2020
Official wording
Reason: The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.
Code information: GTIN 24026704549843 Lot Numbers: 74A1800577, 74G1802121, 74A1801939, 74H1700894, 74B1800363, 74J1700864, 74B1801604, 74J1702489, 74B1802746, 74C1801178, 74K1702257, 74L1700074, 74C1801294 , 74L1701701, 74C1802132, 74M1700121, 74G1800047, 74M1701150, 74G1800891, 74M1701769, 74G1801166
Distribution pattern: ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada
Derived failure modes
-
Unknown
The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.